Safeguarding American Agriculture 

Federal Relay Service 

APHIS is an agency of USDA’s Marketing and Regulatory Programs (Voice/TTY/ASCII/Spanish)

An Equal Opportunity Provider and Employer 1-800-877-8339 

March 29, 2012 

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 12-05 

TO: Biologics Licensees, Permittees, and Applicants 

 Directors, Center for Veterinary Biologics 

 Veterinary Services Leadership Team 

 

FROM: Richard E. Hill, Jr. /s/ Richard E. Hill, Jr. 

 Director 

 Center for Veterinary Biologics 

SUBJECT: Testing Exemptions for Antibody Product Donor Animals 

I. PURPOSE 

The purpose of this Notice is to inform interested parties that the Center for Veterinary 

Biologics (CVB) is in the process of reviewing regulations requiring testing as outlined in 

Title 9, Code of Federal Regulations (9 CFR), Part 113.450. This Notice responds to a 

resolution by the United States Animal Health Association that requests updating the 

testing required of antibody donor animals. 

II. BACKGROUND 

The 9 CFR 113.450 currently requires horses used for antibody production to be tested 

for dourine, glanders, piroplasmosis, brucellosis, and equine infectious anemia (EIA). 

Horses pastured or housed with no other species are not required to be retested annually 

for brucellosis. Annual retesting is required for EIA. Dourine and glanders have been 

eradicated from the United States for several decades. All imported horses must have 

negative test results for dourine, glanders, and piroplasmosis. Although the incidence of 

EIA has been greatly reduced, the disease has not been eradicated from the U.S. horse 

population. 

Cattle are currently required to be tested for brucellosis and tuberculosis before use as 

antibody donors and must be retested annually. The annual retesting of steers has 

become a burden due to the false positive test results encountered and the costs associated 

with the false positive test results. 

United States 

Department of 

Agriculture 

Animal and Plant 

Health Inspection 

Service 

Veterinary Services 

Center for Veterinary 

Biologics 

1920 Dayton Avenue 

PO Box 844 

Ames, IA 50010 

(515) 337- 6100 
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 12-05 

Page 2 

III. POLICY 

The CVB will consider written requests for exemptions to the 9 CFR 113.450 testing 

requirements for the following named diseases for animals of specified species, origin, 

and maintenance, until the applicable 9 CFR regulations are revised. 

A. Horses of United States residency are eligible for an exemption to 9 CFR 

113.450(c)(2)(i)(B) dourine and glanders testing, contingent upon the continued 

lack of either disease in United States resident equines. 

B. Non co-mingled steers originating from certified brucellosis-free herds located in 

Bovine Brucellosis Class Free States, having no diagnosed Brucella abortus in the 

State’s wildlife, may be eligible for an exemption to the 9 CFR 113.450(c)(2)(iv) 

annual retesting for brucellosis. The steers must be maintained with no exposure 

to wildlife susceptible to brucellosis. An exemption to annual retesting for 

brucellosis is limited to steers used solely for products tested according to 

113.450(e)(1). 

C. Non co-mingled steers originating from a Tuberculosis Accredited Herd located in 

a Bovine Tuberculosis Accredited Free State, having no diagnosed bovine 

tuberculosis in the State’s wildlife, may be eligible for an exemption to the 9 CFR 

113.450(c)(2)(iv) annual retesting for tuberculosis. The steers must be maintained 

with no exposure to wildlife susceptible to tuberculosis. An exemption to annual 

retesting for tuberculosis is limited to steers used solely for products tested 

according to 113.450(e)(1). 

Written requests for exemptions should be addressed to the Reviewer assigned to the 

establishment. 

IV. IMPLEMENTATION/ APPLICABILITY 

A statement of the applicable criteria for the exemption and the date of the letter granting 

the exemption shall be included in the Outline of Production, Section I.B. The date of 

implementation will be the date the Outline of Production revision is filed by APHIS.